METHOCEL™ E4M Premium CR HPMC

1 of 29 products in this brand
METHOCEL™ E4M Premium CR HPMC is water-soluble and used in suspensions, granulation, and tablet coating. It serves as a binder, controlled release agent, film former, gelling agent, and immediate release agent in pharmaceuticals and nutraceuticals, and as a binder in ceramics.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Functions: Binder, Controlled Release Agent, Emulsifier, Film Former, Film Former, Gelling Agent, Immediate Release Agent, Lubricant (Internal), Mucoadhesive, Plasticizer, Rheology Modifier, Solubilizer, Surfactant, Sustained Release Agent, Thickener, Viscosity Modifier

Dosage Form: Suspension, Tablets

Labeling Claims: APE-free, Aflatoxin-free, Allergen-free, Aluminum-free, Animal Products-free, Antibiotics-free, BSE-free, Bisphenol A-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, Glycerin-free, Halal, Hormones-free, Hypoallergenic, Irradiation-free, Kosher, Low Odor, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Naturally Derived, Nitrosamines-free, Non-GMO, Not Listed In California Proposition 65, Odor-free, Organic, PAH-free, PFAS-Free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Pareve, Perfluorooctanoic Acid-free, Pesticide-free, Phthalates-free, Plant-Based, Plasticizer-free, Preservative-free, Residual Solvent -Free, Sewage Sludge Free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, USP 232 Elemental Impurities Free, VOC-free, Vegan, Vegetarian, Zero Calorie

Certifications & Compliance: British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), Directive 1333/2008/EC, Directive 2009/48/EC, Doping-Free, EU Packaging Directive (94/62/EC), EXCiPACT, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FCC Compliant, FDA 21 CFR 101.9, FDA 21 CFR 172.874, FDA 21 CFR 182.1480, FDA Compliant, FDA Food Safety Modernization Act (FSMA), FFDCA, FSSC 22000, GMP, Generally Recognized As Safe (GRAS), Halal, Hazard Analysis Critical Control Point (HACCP), ICH Q3C, ISO 14001, ISO 9001, Indian Pharmacopeia, Japan Pharmacopeia (JP), National Formulary (NF), Organic Certified, Orthodox Union Kosher, Regulation (EC) No. 1333/2008, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1169/2011, Regulation (EU) No. 1272/2008, Regulation (EU) No. 1829/2003, Regulation (EU) No. 1830/2003, Regulation (EU) No. 231/2012, USDA Organic, United States Pharmacopeia (USP), cGMP

Manufacturing Technology: Granulation, Tablet Coating

Synonyms: Hydroxypropyl methyl cellulose ether, Methyl hydroxypropyl cellulose, Cellulose hydroxypropyl methyl ether, 2-Hydroxypropyl methyl cellulose, 2-Hydroxypropyl methyl cellulose ether, Hydroxypropyl methyl cellulose, HPMC, Hypermellose, Hypromellose

  • TypeDocument Name
  • Brochure

    IFF Pharma Solutions Portfolio Brochure

    View

  • Brochure

    METHOCEL™ Cellulose Ethers Brochure

    View

View All Documents

Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2% solution)*5.0 - 8.0-USP/EP/JP/CHP
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCurrent USP Negative
Pseudomonas aeruginosa*Absent/1gCurrent USP Negative
Salmonella*Absent/10gCurrent USP Negative
Staphylococcus aureus*Absent/gCurrent USP Negative
Yeast and Mold Count*max. 100/gCurrent USP Combined Mold And Yeast
Total Plate Count*max. 100/gCurrent USP Total Aerobic
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content*7.0 - 12.0%USP/EP/JP/CHP
Methoxyl Content*28.0 - 30.0%USP/EP/JP/CHP
Specifications
ValueUnitsTest Method / Conditions
Opalescence*Pass-Current EP Opalescence
Color Evaluation*Pass-Current EP Solution Color
Identification*Pass-USP/EP/JP/CHP
Residual Solvent*Pass-Current USP/EP/JP
Sulfated Ash Content*max. 1.5%Current USP/EP/JP
Loss on Drying*max. 5.0%USP/EP/JP/CHP
Residue on Ignition*max. 1.5%USP/JP/CHP
Apparent Viscosity (at 20°C, 2% in water)*2,663 - 4,970mPa.sUSP/EP/JP/CHP
Apparent Viscosity (Target)*3550mPa.s-
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 10mg/KgUSP/EP/JP/CHP
Magnetic Iron Content*max. 5mg/KgPSM 100041
Magnetic Iron Content (Target)*0mg/Kg-
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 149 micron, through 100 U.S. STD.Sieve)*min. 95.0%PSM 100669
Screen (< 420 micron, through 40 U. S. STD. Sieve)*min. 99.0%PSM 100669
Note

*PHS - All section names come under PHS
[AB] = Audit Basis

Regulatory & Compliance

Technical Details & Test Data

Nutritional Information
USA
Nutritional Information (per 100 g)
Carbohydrates (g) 0
Non-Digestible Carbohydrates (g) 93.5
Water (g) 5
Ash (g) (includes salt and iron) 1.5
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

 

Additional Nutrient Information (per 100 g)
Calories (Energy) (kcal) 0
Cholesterol (mg) 0
Total Dietary Fiber (g) 0
Soluble Fiber (g) 93.5
Insoluble Fiber (g) 0
Sugars (g) 0
Added Sugars (g) 0
Sodium (mg) 390
Chloride (mg) 610
Potassium (mg) 0
Magnesium (mg) 0
Iron (mg) 15
Zinc (mg) 0
Total Vitamin A (IU) 0
Vitamin C (mg) 0
Thiamin (mg) 0
Riboflavin (mg) 0
Vitamin D (IU) 0
Niacin (mg) 0
Vitamin B6 (mg) 0
Calcium (mg) 0
Phosphorus (mg) 0

 

European Union
Nutritional Information (per 100 g)
Energy

748 kJ / 187 kcal

Fat 0 g
Of which saturates 0 g
Carbohydrates 0 g
Of which sugars 0 g
Fibre 93.5 g
Protein 0 g
Salt 1.5 g

 

Australia & New Zealand
Nutritional Information (per 100 g)
Energy (kJ) 748
Carbohydrates (g) 0
Dietary Fibre (g) 93.5
Water (g) 5
Ash (g) (includes salt and iron) 0.4
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

Packaging & Availability